FDA Policy/General
Federal Register notice: FDA is requesting information to better understand the status of trading partners’ (manufacturers, wholesale distributors, dispensers, and repackagers) interoperable systems and processes for enhanced drug distribution security. The agency says that trading partners should be using the current stabilization period to continue to build and validate secure,
FDA Policy/General
A new FDA final rule sets five standards that the agency says drug marketers must follow to ensure their direct-to-consumer advertisement’s “major statement” is presented in a clear, conspicuous, and neutral manner. The rule, Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a
Drugs
Bayer says it is stopping its Phase 3 OCEANIC-AF study evaluating asundexian compared to apixaban (Bristol-Myers Squibb’s Eliquis) in patients with atrial fibrillation at risk for stroke due to an “inferior efficacy” comparison. The decision is based on the recommendation of the study’s independent data monitoring
Devices
FDA is warning healthcare professionals not to use Cardinal Health Monoject syringes with syringe pumps and patient-controlled analgesia (PCA) pumps while the agency further evaluates their compatibility with the devices. Recently, Cardinal Health recalled the syringes because their dimensions differ from the previously branded syringes and they may be
Drugs
Janssen Pharmaceutical has submitted a supplemental BLA for Rybrevant (amivantamab-vmjw) in combination with chemotherapy (carboplatin and pemetrexed) for treating patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution after disease progression on or
Drugs
FDA has issued Dr. Reddy’s Laboratories a 10-item Form FDA-483 after concluding an inspection 10/27 at the firm’s Telangana, India manufacturing facility. Agency investigators cited Dr. Reddy’s for not maintaining/cleaning equipment and utensils at appropriate intervals. They also took issue with the facility’
FDA Policy/General
Federal Register notice: FDA is making savailable a final guidance entitled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act” and a draft guidance entitled “Select Updates for the 506J Guidance: 506J Device List and Additional Notifications.
FDA Policy/General
Federal Register notice: FDA is announcing a 2/6/2024 meeting of the Medical Devices Advisory Committee’s General Hospital and Personal Use Devices Panel. It is scheduled to discuss and make recommendations on medical device supply chain resiliency and shortage issues, including the agency’s “506J Device List.” Manufacturers
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Assessing the Credibility of Computational Modeling and Simulation (CM&S) in Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff.” The document provides a risk-informed framework for credibility assessment of CM&S used
Drugs
FDA has approved an AstraZeneca NDA for Truqap (capivasertib) for use with fulvestrant in adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test
Drugs
FDA has approved a Merck NDA for Keytruda (pembrolizumab) and its use with fluoropyrimidine- and platinum-containing chemotherapy for treating (first line) adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Approval was based on data from KEYNOTE-859 (NCT03675737), a multicenter, randomized, double-
Devices
Asensus Surgical has recalled (Class 1) its Senhance Surgical System due to malfunctions that cause unintended movement of the robotically assisted surgical device. “This issue presented itself as an uncontrolled arm motion of the Laparoscope Instrument Actuator (LIA) where the LIA rotated continuously in one direction after the Surgeon removed
Devices
Braun Medical has recalled (Class 1) its Infusomat Space Volumetric Infusion Pump System due to faulty occlusion alarms. “On certain models, an occlusion alarm may sound when no occlusion exists, causing the pump to stop the delivery of medications, such as high-risk medications like vasopressors,” a recall notice says.
Drugs
FDA has approved Astellas Pharma’s Xtandi (enzalutamide) for an expanded use — treating non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). Approval was based on data from EMBARK (NCT02319837), a randomized, controlled clinical trial involving almost 1,100 patients with
FDA Policy/General
Federal Register notice: FDA is correcting a notice that appeared in the 7/8/2022 Federal Register announcing an agency determination of the regulatory review period for Genentech’s Rozlytrek tablets (entrectinib), indicated for treating certain adult patients with metastatic non-small cell lung cancer, among other indications. The earlier
FDA Policy/General
Federal Register notice: FDA is announcing a 2/2/2024 Medical Devices Advisory Committee’s Anesthesiology and Respiratory Therapy Devices Panel meeting. Panel members are scheduled to discuss ongoing concerns that pulse oximeters may be less accurate in individuals with darker skin pigmentation. They will also discuss an approach to
Devices
FDA has issued a final guidance, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act, to assist manufacturers in providing timely, informative notifications about changes in the production of certain medical devices that will help
Drugs
FDA says it has published 40 product-specific guidances (PSGs) with recommendations for developing generic drugs and generating evidence to support ANDA approvals. The latest batch includes 22 new and 18 revised PSGs, FDA says. There are 30 PSGs for products with approved ANDAs, including 16 complex products. Some 22
Devices
FDA has published a guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions, to assist the medical device industry in assessing the credibility of computational modeling used to support medical device PMA, HDE, and IDE applications, 510(k)s, and de novo classification requests, or qualification
Drugs
A new Iqvia Institute report says drug shortages continue to increase in the U.S., with more shortages being reported than resolved. As of June, the report says, there were 132 active shortages, with 75% of them having been active for more than one year and 58% ongoing for more
Drugs
FDA commissioner Robert Califf says the Healthcare Distribution Alliance, which has provided aggregate information on the distribution of Covid vaccines from distributors into the field, could be of even greater assistance to FDA by also providing aggregate information on the distribution of Covid-19 therapeutics. “This kind of added transparency,
FDA Policy/General
The central Utah federal court has entered two consent decrees of permanent injunction against Evig LLC and Premium Production LLC, both of St. George, UT, over their distribution and marketing of Balance of Nature products. An FDA release says the products are marketed as dietary supplements, but their labeling “rendered